Following the formal safety review of Cohort 1, no safety or tolerability issues were observed, allowing the company to move forward with Cohort 2. The company plans on releasing more detailed results from Phase 1 later in 2025 following completion of additional dose cohorts. SAN FRANCISCO, CALIFORNIA, May 19, 2025 (GLOBE NEWSWIRE) -- GT Biopharma, Inc. (the “Company”) (NASDAQ: GTBP), a clinical stage immuno-oncology company focused on developing innovative therapeutics based on the Company's proprietary Tr ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ Quarterly report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the quarterly period ended March 31, 2025. ☐ Transition report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the transition period from __________ to ____________. Commission File Number 001-40023 GT BIOPHARMA, INC. (Exact name of registrant as specified in its charter) (State or other jurisdiction of inco ...

SAN FRANCISCO, CALIFORNIA, March 04, 2025 (GLOBE NEWSWIRE) -- GT Biopharma, Inc. (the “Company”) (NASDAQ: GTBP), a clinical stage immuno-oncology company focused on developing innovative therapeutics based on the Company's proprietary TriKE® natural killer (NK) cell engager platform, today announced that Jeffrey Miller, MD1 from the University of Minnesota Medical School2 will participate as an expert speaker at the 10th Anniversary of the Innate Killer Summit being held March 3-5, 2025 in San Diego, CA. 10 ...

Core Points - GT Biopharma, Inc. has entered into definitive agreements for the exercise of existing warrants to purchase 302,069 shares of common stock at an exercise price of $4.35 per share, expected to generate approximately $0.7 million in gross proceeds [1] - The company will issue new unregistered warrants to purchase up to 604,138 shares at an exercise price of $2.02 per share in exchange for the immediate exercise of existing warrants at $2.27 per share [3] - The offering is expected to close on or about February 27, 2025, and the net proceeds will be used for working capital and general corporate purposes [4] Company Overview - GT Biopharma is a clinical stage biopharmaceutical company focused on developing immuno-oncology therapeutic products based on its proprietary TriKE® NK cell engager platform, which enhances the cancer-killing abilities of natural killer cells [7] - The company has an exclusive worldwide license agreement with the University of Minnesota to further develop and commercialize therapies using TriKE® technology [7]

SAN FRANCISCO, CALIFORNIA, Feb. 25, 2025 (GLOBE NEWSWIRE) -- GT Biopharma, Inc. (the “Company”) (NASDAQ: GTBP), a clinical stage immuno-oncology company focused on developing innovative therapeutics based on the Company's proprietary TriKE® natural killer (“NK”) cell engager platform, today announced that it has filed a Request for Withdrawal with the U.S. Securities and Exchange Commission (“SEC”) with respect to the withdrawal of the Company’s Registration Statement on Form S-1 (File No. 333-284032) that ...

Operating Expenses - Total operating expenses for the year ended December 31, 2024, were $14,364,000, a 6% increase from $13,576,000 in 2023[226]. - Selling, general, and administrative expenses increased by approximately $3.4 million to $8,336,000 in 2024, mainly due to higher legal fees and settlement expenses[229]. - Research and development expenses decreased by $668,000 to $5,798,000 in 2024, primarily due to a reduction in project materials costs[227]. Financial Performance - The net loss for the year ended December 31, 2024, was $13,162,000, representing a 73% increase from a net loss of $7,597,000 in 2023[235]. - Cash used in operating activities was approximately $12.9 million for the year ended December 31, 2024, compared to $8.9 million in 2023[241]. - Interest income decreased by $378,000 to $402,000 in 2024, primarily due to lower short-term investment balances[231]. Assets and Liabilities - Current assets decreased by $9,824,000 to $4,232,000 as of December 31, 2024, while current liabilities decreased by $731,000 to $5,902,000[245]. - The change in fair value of warrant liability decreased by approximately $4.0 million to $800,000 in 2024, primarily due to a decline in the company's stock price[233]. Business Viability - The company has no product candidates approved for sale and has not generated any revenue from product sales, raising substantial doubt about its ability to continue as a going concern[236]. - The company plans to increase direct clinical and preclinical expenses in 2025 as it advances its next-generation GTB-3650 product in the clinic[228].

Initial data from the Phase 1 trial expected in 2025 SAN FRANCISCO, CALIFORNIA, Jan. 27, 2025 (GLOBE NEWSWIRE) -- GT Biopharma, Inc. (the "Company") (NASDAQ:GTBP), a clinical stage immuno-oncology company focused on developing innovative therapeutics based on the Company's proprietary natural killer (NK) cell engager TriKE® platform, today announced that the first patient was dosed in a Phase 1 trial evaluating GTB-3650, its second-generation TriKE, for the treatment of relapsed or refractory (r/r) CD33 exp ...

Product Development - GT Biopharma is focused on developing immuno-oncology products using proprietary TriKE and Dual Targeting TriKE® platforms to enhance the cancer-killing abilities of natural killer (NK) cells[106]. - The product pipeline includes GTB-3650, which targets CD33 for treating relapsed/refractory AML and high-risk MDS, with an IND application filed in December 2023 and FDA clearance received in June 2024[117]. - GTB-5550 targets B7-H3 on advanced solid tumors, with a pre-IND packet submitted to the FDA in October 2023 and IND filing anticipated in the first half of 2025[118]. - GTB-3650 demonstrated increased potency compared to its predecessor GTB-3550, leading to a strategic pivot in clinical development[111]. - The company aims to leverage camelid nanobody technology for next-generation TriKEs, which may offer greater affinity and potency against target antigens[114]. - The initial study for GTB-3650 will test it as a monotherapy with a dosing schedule of two weeks on and two weeks off, targeting enrollment in the second half of 2024[117]. - GTB-7550 is in development for lupus and other autoimmune disorders, utilizing a trispecific molecule approach[119]. - The company is establishing processes for scalable production of investigational new drug (IND) ready moieties following specific TriKE designs[107]. - GT Biopharma's collaboration with the Masonic Cancer Center at the University of Minnesota has been pivotal in advancing its research and development efforts[108]. - The company is generating additional intellectual property for specific moieties within its TriKE platform[108]. Financial Performance - Total operating expenses for the three months ended September 30, 2024, increased by 15% to $3,604,000 compared to $3,122,000 in the same period of 2023[126]. - Research and development expenses decreased by $57,000 (4%) for the three months and by $1,241,000 (24%) for the nine months ended September 30, 2024, primarily due to a decrease in project materials costs[128][127]. - Selling, general, and administrative expenses increased by approximately $1.1 million (90%) for the three months and by $3.0 million (84%) for the nine months ended September 30, 2024, mainly due to higher legal and professional fees[130][127]. - Net loss for the three months ended September 30, 2024, was $3,411,000, an increase of $995,000 (41%) compared to a net loss of $2,416,000 in 2023[137][138]. - Net cash used in operating activities was $10.4 million for the nine months ended September 30, 2024, compared to $6.8 million in the same period of 2023[147][144]. - Cash and cash equivalents at the end of the period increased to $6,511,000 as of September 30, 2024, from $2,648,000 at the end of September 2023[147]. - The company anticipates an increase in direct clinical and preclinical expenses in the second half of 2024 as it plans to advance its GTB-3650 product into clinical trials[129]. - The change in fair value of warrant liability decreased by approximately $390,000 for the three months ended September 30, 2024, compared to the same period in 2023[135]. - The company recorded a net loss of approximately $9.4 million for the nine months ended September 30, 2024, raising substantial doubt about its ability to continue as a going concern[140]. - Current assets decreased by $7,297,000 to $6,759,000 as of September 30, 2024, compared to $14,056,000 as of December 31, 2023[149]. Legal Matters - The Company filed an AAA Arbitration Demand against former CFO Manu Ohri on July 22, 2024, for breach of fiduciary duties and breach of contract, seeking damages and a declaratory judgment[156]. - On November 14, 2023, former interim CEO Dr. Gregory Berk filed a lawsuit alleging discrimination and retaliation, which the Company expects to be dismissed shortly[157]. - The Company has no off-balance sheet arrangements as of September 30, 2024[150]. - There were no changes in internal controls over financial reporting during the most recent fiscal quarter that materially affected the controls[155]. - The Company believes it has recorded appropriate accruals for the legal matters mentioned[157]. - The effectiveness of the Company's disclosure controls and procedures was evaluated and deemed effective as of September 30, 2024[150]. - The Company does not expect its internal control over financial reporting to prevent or detect all errors and fraud due to inherent limitations[152]. - Management is responsible for establishing and maintaining adequate internal control over financial reporting[151]. - The design of the control system must consider resource constraints and the cost-benefit relationship of controls[152]. - The Company is unable to determine the probability of the outcome of the Ohri matter or a range of reasonably expected losses at this early stage[156]. - TWF Global, LLC filed a complaint against the Company regarding two Convertible Promissory Notes, alleging non-delivery of shares due on conversion in February 2021[158]. - The Company filed a motion to dismiss the complaint, claiming improper forum as disputes should be filed in New York courts[158]. - TWF voluntarily dismissed its complaint in California, and the Company initiated an interpleader action in New York to determine proper registration of shares between TWF and Z-One LLC[158]. - On February 5, 2024, the Company sought a default judgment against TWF, which was denied without prejudice by the court[158]. - Z-One filed a motion for summary judgment on May 9, 2024, indicating a settlement of its dispute with TWF over the Company's shares[158]. - The court has scheduled a hearing for Z-One's motion on November 14, 2024[158]. - The Company maintains that claims related to the Convertible Promissory Notes are without merit and will continue to defend against them vigorously[158].

GTB-3650 TriKE® Phase 1 trial first patient dosed expected in Q4 2024; initial clinical data expected in Q2 2025GTB-5550 TriKE® IND submission for treatment of B7H3 positive solid tumors expected in 1H 2025GTB-5550 Phase 1 dose escalation basket trial initiation expected in 2025 evaluating multiple solid tumor types, including prostate, breast, head and neck, ovarian, lung, liver, and GIGTB-7550 TriKE® targets CD19 and is in preclinical development for the treatment of Lupus and other autoimmune indications ...

SAN FRANCISCO, CALIFORNIA, Sept. 26, 2024 (GLOBE NEWSWIRE) -- GT Biopharma, Inc. (the "Company") (NASDAQ: GTBP), a clinical stage immuno-oncology company focused on developing innovative therapeutics based on the Company's proprietary natural killer (NK) cell engager TriKE® platform, today announced that Dr. Jeffrey Miller, MD1, from the University of Minnesota Medical School2 and GT Biopharma's Consulting Senior Medical Director, will participate in a panel discussion on innovative therapies for acute myel ...